Job Description
Job Description
Here are the job details for your review:
Job Title: Inspector 2
Location: Newton MA 02466
Duration: 12 months
Shift hours: 8:30 am - 5:00 pm
Description/Position Summary:
- The Quality Control Inspector is responsible for ensuring that electromechanical components and single-use sterile consumable components and assemblies comply with company and regulatory standards.
- Key responsibilities include inspecting mechanical, electrical (including PCB/PCBA) and single-use consumable components and assemblies, while maintaining accurate quality documentation.
- The role also supports compliance with an ISO 13485–certified quality management system and contributes to safeguarding product quality, patient safety, and continuous improvement in the manufacturing process.
- Perform incoming part inspections with emphasis on electromechanical components and sterile single use consumable components.
- Conduct in-process inspections of assemblies to ensure compliance with design and sterile-use requirements.
- Inspect sub assemblies and finished products, including single-use sterile consumables, for conformance to specifications.
- Generate and manage Non conformance Reports (NCMRs) as required.
- Generate, review and maintain inspection records and reports in accordance with Good Documentation Practices (GDP).
- Review and maintain Part/Device History Records (DHRs), ensuring traceability of sterile consumables and electromechanical assemblies.
- Support continuous improvement, part investigations, and compliance initiatives across electromechanical and sterile consumable workflows
- Support Test Method Validation (TMV) (i.e., Gage R&R Studies) and Inspection Method development activities.
- Perform other quality-related duties as assigned by management.
Experience:
Key Requirements:
- Demonstrated experience operating under ISO 13485 or ISO 9001(or equivalent) quality systems (medical device manufacturing environment preferred).
- Proficiency in Good Documentation Practices (GDP) and controlled environment requirements for sterile consumables.
- Experience with Coordinate Measurement Machines (CMM) – tactile and vision-based, strongly preferred.
- Certified Mechanical Inspector (or equivalent) preferred
- Familiarity with applicable standards: ANSI, ASTM, MIL, IEC test methods.
- Skilled in the use of precision hand tools for mechanical and electrical inspection.
- Proficiency with optical comparators and vision measurement systems (e.g., Micro-Vu).
- Ability to measure and verify geometric tolerances in precision electromechanical and consumable parts.
- Competence in interpreting wiring diagrams and PCB schematics for electromechanical devices.
- Prior experience in PCB/PCBA inspection and IPC 610 methods strongly preferred.
- Familiarity with ERP systems for tracking components and consumables (SAP experience strongly preferred).
- Strong working knowledge of Microsoft Office, especially Excel, for data entry and analysis.
- High attention to detail, particularly in maintaining traceability and sterility documentation.
- Ability to work overtime.
Education:
High school diploma or GED required